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    Clinical Trial Results:
    Phase I/II feasibility study of Brentuximab Vedotin in refractory / relapsed Hodgkin lymphoma patients who are treated by chemotherapy (ICE) in second line and eligible for autologous transplantation

    Summary
    EudraCT number
    		 2014-002722-13
    Trial protocol
    		 FR   BE  
    Global end of trial date
    13 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2022
    First version publication date
    17 Dec 2022
    Other versions
    Summary report(s)
    		 BV-ICE_CSR_Final synopsis

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BV-ICE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02686346
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LYSARC
    Sponsor organisation address
    165 Chemin du grand Revoyet - Batiment 2D, Pierre Benite Cedex, France, 69495
    Public contact
    Alexia Schwartzmann, LYSARC, +33 472 66 93 33, alexia.schwartzmann@lysarc.org
    Scientific contact
    Dr Aspasia Stamatoullas-Bastard, LYSA, +33 2 32 08 25 89, aspasia.stamatoullas@chb.unicancer.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I To determine the MTD and/or RP2D (Recommended Phase II dose) of BV when administered to adult Hodgkin’s lymphoma patients treated with ICE. Phase II To evaluate the efficacy of BV in patient treated with ICE as first salvage treatment (establish the fraction of responding patients – metabolic CR) acccording to Lugano classification after the second cycle.
    Protection of trial subjects
    Patients who do not answer to study treatment will be treated according to site's standart of care.
    Background therapy
    		 - ICE: Etoposide 100 mg/m², Carboplatine AUC (5) max 800mg, Ifosfamide + Mesna 5 g/m² - Autologous peripheral blood stem cell transplantation (ASCT) with BEAM (BiCNU = carmustine, Etoposide, Aracytine = cytarabine, Melphalan) or BAM (Busulfan, Aracytine = cytarabine, Melphalan) conditionning regimen
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    09 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 49
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    53
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Phase I - Recruitment by cohorts of 3 patients (France only) * Cohort 1: Mar. 9th 2016 to Jun. 6th 2016 * Cohort 2: Aug. 8th 2016 to Sep. 19th 2016 * Cohort 3: Nov. 17th 2016 to Jan. 24th 2017 Phase II - France and Belgium * France: Jun. 20th 2017 to Mar. 15th 2018 * Belgium: Aug 25th 2017 to Mar. 27th 2018

    Pre-assignment
    Screening details
    		 Patients with Hodgkin lymphoma refractory to first line or in first relapse and eligible for high-dose treatment followed by autologous peripheral blood stem cell transplantation. Screening procedure: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable for phase I and II

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase I - Cohort 1
    Arm description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Arm title
    		 Phase I - Cohort 2
    Arm description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Arm title
    		 Phase I - Cohort 3
    Arm description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Arm title
    		 Phase II
    Arm description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Number of subjects in period 1
    		Phase I - Cohort 1 Phase I - Cohort 2 Phase I - Cohort 3 Phase II
    Started
    3
    4
    3
    44
    Completed
    3
    4
    3
    42
    Not completed
    0
    0
    0
    2
         Consent withdrawn by subject
    -
    -
    -
    1
         Non proven histology
    -
    -
    -
    1
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable since no treatment administration during follow up period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase I - Cohort 1
    Arm description
    		 Cycle 1 to 3: BV 1.2mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Arm title
    		 Phase I - Cohort 2
    Arm description
    		 Cycle 1 to 3: BV 1.8mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Arm title
    		 Phase I - Cohort 3
    Arm description
    		 Cycle 1 to 3: BV 1.8mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Arm title
    		 Phase II
    Arm description
    		 Cycle 1 to 3: BV 1.8mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    L01XC12
    Other name
    ADCETRIS
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg vials of a lyophilized powder, to reconstituate with sterile watter and diluted in a 150 mL infusion bag containing 0.9% Sodium Chloride Injection

    Number of subjects in period 2
    		Phase I - Cohort 1 Phase I - Cohort 2 Phase I - Cohort 3 Phase II
    Started
    3
    4
    3
    42
    Completed
    4
    3
    3
    42
    Not completed
    0
    1
    0
    0
         Transferred to other arm/group
    -
    1
    -
    -
    Joined
    1
    0
    0
    0
         Transferred in from other group/arm
    1
    -
    -
    -
    Period 3
    Period 3 title
    Follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase I - Cohort 1
    Arm description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years
    Arm type
    		 Follow up period

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Phase I - Cohort 2
    Arm description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years
    Arm type
    		 Follow up period

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Phase I - Cohort 3
    Arm description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years
    Arm type
    		 Follow up period

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Phase II
    Arm description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years
    Arm type
    		 Follow up period

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Phase I - Cohort 1 Phase I - Cohort 2 Phase I - Cohort 3 Phase II
    Started
    4
    3
    3
    42
    Completed
    4
    3
    3
    42

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 54 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 53 53
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Phase I and phase II patients are all from 18 to 65 years old.
    Units: years
        arithmetic mean (standard deviation)
    		 34.8 ( 13.1 ) -
    Gender categorical
    Phase I and phase II patients can be either Female or Male
    Units: Subjects
        Female
    		 21 21
        Male
    		 33 33
    Subject analysis sets

    Subject analysis set title
    Phase I set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients included and treated in Phase I dose-escalation study.

    Subject analysis set title
    Phase II Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients included and treated in phase II study.

    Subject analysis sets values
    		 Phase I set Phase II Set
    Number of subjects
    10
    42
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    10
    41
        From 65-84 years
    1
        85 years and over
    Age continuous
    Phase I and phase II patients are all from 18 to 65 years old.
    Units: years
        arithmetic mean (standard deviation)
    33.8 ( 12.6 )
    35.7 ( 13.4 )
    Gender categorical
    Phase I and phase II patients can be either Female or Male
    Units: Subjects
        Female
    4
    15
        Male
    6
    27

    End points

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    End points reporting groups
    Reporting group title
    Phase I - Cohort 1
    Reporting group description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments

    Reporting group title
    Phase I - Cohort 2
    Reporting group description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments

    Reporting group title
    Phase I - Cohort 3
    Reporting group description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments

    Reporting group title
    Phase II
    Reporting group description
    		 Assessements: medical history, HL history, staging, CBC, biochemestry, serologies, pregnancy, CT scan, PET scan, cardiac and pulmonary assessments
    Reporting group title
    Phase I - Cohort 1
    Reporting group description
    		 Cycle 1 to 3: BV 1.2mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3

    Reporting group title
    Phase I - Cohort 2
    Reporting group description
    		 Cycle 1 to 3: BV 1.8mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3

    Reporting group title
    Phase I - Cohort 3
    Reporting group description
    		 Cycle 1 to 3: BV 1.8mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3

    Reporting group title
    Phase II
    Reporting group description
    		 Cycle 1 to 3: BV 1.8mg/kg (100kg max) + ICE, every 21 days Cycle 4: BV 1.8mg/kg (100kg max) alone, 21 days after day 1 cycle 3
    Reporting group title
    Phase I - Cohort 1
    Reporting group description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years

    Reporting group title
    Phase I - Cohort 2
    Reporting group description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years

    Reporting group title
    Phase I - Cohort 3
    Reporting group description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years

    Reporting group title
    Phase II
    Reporting group description
    		 Visit every 3 months during the first year, then every 6 months during the next 2 years

    Subject analysis set title
    Phase I set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients included and treated in Phase I dose-escalation study.

    Subject analysis set title
    Phase II Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients included and treated in phase II study.

    Primary: Dose Limiting Toxicty DLT

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    End point title
    		 Dose Limiting Toxicty DLT [1]
    End point description
    Toxicity will be assessed using the NCI CTCAE version 4.0. A DLT is defined as any of the following events (toxicity or abnormal laboratory value) that is assessed as possibly related to BV or BV+ICE, occurring prior initiation of the second cycle : Any grade ≥3 non-hematological toxicity with a duration > 7 days Febrile Neutropenia grade 4 with hospitalization during 7 days or more Bleeding grade 4 with life threatening consequently Progressive multifocal Leukoencephalopathy
    End point type
    Primary
    End point timeframe
    Prior to initiation of cycle 2
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In this single-arm study, no statistical comparisons are performed between arms.
    End point values
    		 Phase I - Cohort 1 Phase I - Cohort 2 Phase I - Cohort 3
    Number of subjects analysed
    3
    4
    3
    Units: Patient with DLT
    0
    0
    0
    No statistical analyses for this end point

    Primary: Complete Metabolic Response after C2

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    End point title
    		 Complete Metabolic Response after C2 [2]
    End point description
    Complete Metabolic Response (CMR) as judged by the center by Lugano classification after the second cycle.
    End point type
    Primary
    End point timeframe
    Evaluation after cycle 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In this single-arm study, no statistical comparisons are performed between arms.
    End point values
    		 Phase II Set
    Number of subjects analysed
    42
    Units: Patients with CMR
        Complete metabolic response
    26
        Partial metabolic response
    13
        No metabolic response
    2
        Progressive metabolic disease
    0
        Not evaluated
    1
    No statistical analyses for this end point

    Secondary: Progression Free Survival at 24 months

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    End point title
    		 Progression Free Survival at 24 months
    End point description
    PFS: patient has a failure event at date of progression or death from any cause.
    End point type
    Secondary
    End point timeframe
    Patients followed up to 3 years from end of treatment.
    End point values
    		 Phase II Set
    Number of subjects analysed
    42
    Units: months
        number (confidence interval 64.3%)
    64.3 (47.9 to 76.7)
    Attachments
    		 BVICE PFS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs of grade 2-5 for infections and neurological toxicities and AEs of grade 3-5 for other toxicities regardless relationship to investigational product occurring from the date of informed consent signature to 30 days after last BV administration.
    Adverse event reporting additional description
    Signs, symptoms and physical findings indicative of lymphoma or progression of lymphoma are not to be reported as “Adverse Event”. “Alopecia” and “lymphopenia” toxicity will never be reported as “Adverse event”. Monitoring SDV on site was driven for 100% of data
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Subjects receiving BV (global study)
    Reporting group description
    		 Subjects who received experimental BV during the study (52)

    Serious adverse events
    		 Subjects receiving BV (global study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 52 (38.46%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Investigations
    INVESTIGATIONS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    INJURY, POISONING AND PROCEDURAL COMPLICATIONS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    VASCULAR DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    BLOOD AND LYMPHATIC SYSTEM DISORDERS
         subjects affected / exposed
    9 / 52 (17.31%)
         occurrences causally related to treatment / all
    12 / 18
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL DISORDERS
         subjects affected / exposed
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    HEPATOBILIARY DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    INFECTIONS AND INFESTATIONS
         subjects affected / exposed
    11 / 52 (21.15%)
         occurrences causally related to treatment / all
    7 / 12
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Subjects receiving BV (global study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 52 (88.46%)
    Vascular disorders
    VASCULAR DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    General disorders and administration site conditions
    GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Psychiatric disorders
    PSYCHIATRIC DISORDERS
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Investigations
    INVESTIGATIONS
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    7
    Injury, poisoning and procedural complications
    INJURY, POISONING AND PROCEDURAL COMPLICATIONS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Cardiac disorders
    CARDIAC DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Nervous system disorders
    NERVOUS SYSTEM DISORDERS
         subjects affected / exposed
    2 / 52 (3.85%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    BLOOD AND LYMPHATIC SYSTEM DISORDERS
         subjects affected / exposed
    41 / 52 (78.85%)
         occurrences all number
    181
    Gastrointestinal disorders
    GASTROINTESTINAL DISORDERS
         subjects affected / exposed
    5 / 52 (9.62%)
         occurrences all number
    7
    Hepatobiliary disorders
    HEPATOBILIARY DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1
    Infections and infestations
    INFECTIONS AND INFESTATIONS
         subjects affected / exposed
    15 / 52 (28.85%)
         occurrences all number
    19
    Metabolism and nutrition disorders
    METABOLISM AND NUTRITION DISORDERS
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2016
    - New IB available - ICF updated accordingly - Protocol updated accordingly
    27 Sep 2018
    - Addition of an addendum to ICF to comply with RGPD
    31 Oct 2019
    - New IB available
    24 Sep 2020
    - New IB available
    24 Jun 2021
    - New IB available

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 Jun 2016
    Suspension of inclusion between cohort 1 (Phase I) and cohort 2 (Phase I) to look after safety data
    08 Aug 2016
    19 Sep 2016
    Suspension of inclusion between cohort 2 (Phase I) and cohort 3 (Phase I) to look after safety data
    17 Nov 2016
    24 Jan 2017
    Suspension of inclusion between cohort 3 (Phase I) and Phase II to look after safety data
    20 Jun 2017

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35975738
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